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STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery.

STARDUST MED is indicated for hair removal and permanent hair reduction.

Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime

STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin.

STARSDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch.

A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpiece:

• -808 nm Laser diode.

The provided text is a 510(k) summary for the STARDUST MED device and focuses on establishing substantial equivalence to a predicate device (MT ONE DIAMOND - K191942). It relies heavily on comparing technical specifications and intended use, and states that non-clinical testing supports the device's technological characteristics and performance.

However, the document does not contain information about:

• Acceptance criteria for a specific performance study.
• The device's reported performance against such criteria.
• Sample sizes used for a test set or data provenance for any clinical performance study.
• The number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Any Multi Reader Multi Case (MRMC) comparative effectiveness study.
• Any standalone performance study (algorithm only).
• The type of ground truth used for any performance study.
• Sample size for the training set or how ground truth was established for a training set.

The "Performance data" section only mentions:

• Safety and electromagnetic compatibility (EMC) testing: Compliance with IEC 60601-2-22 and IEC 60601-1-2 standards. This is a regulatory compliance, not a performance study as typically understood for a medical device's intended use (e.g., hair removal efficacy).
• Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance. This also relates to regulatory compliance and software quality, not a direct measure of hair removal performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the detailed information points you listed, because this information is not present in the provided document. The 510(k) summary emphasizes the device's similarity to a predicate device and adherence to safety and software standards, rather than presenting a clinical performance study with specific acceptance criteria related to its intended use (hair removal).

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